Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy

NCT04526886 | Completed Results DMC

• 1 other identifier: D20125
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The study is testing an intervention of an investigator-developed chemotherapy dose adjustment algorithm. The primary objective of this study is to evaluate the effectiveness of the chemotherapy dose adjustment algorithm for reducing unplanned delays in patients receiving FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)-type chemotherapy, while maintaining acceptable chemotherapy dose-intensity.

Conditions

Colorectal Cancer; Gastric Cancer; Esophageal Cancer; Ampullary Cancer; Small Bowel Cancer; Appendix Cancer

Keywords

neutropenia; thrombocytopenia; FOLFOX; dose adjustment

Outcome Measures

Primary Outcomes (1)

• Unplanned Chemotherapy Treatment Delay

  Number of patients with any interruption of chemotherapy leading to a cycle length of \>18 days that is not anticipated as of day 3 of the preceding treatment cycle.

  Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)

Secondary Outcomes (2)

• Composite Safety Endpoint

  Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)

• Relative Dose Intensity of Chemotherapy

  Through day 1 of cycle 6 of FOLFOX chemotherapy (cycle length is 14 days)

Study Arms (1)

Study Arm

EXPERIMENTAL

All patients in this single-arm study will be exposed to the experimental chemotherapy dose-adjustment algorithm.

Other: Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy

Interventions

Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy OTHER

Chemotherapy dose-adjustment algorithm for FOLFOX chemotherapy

Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18
• Diagnosis of adenocarcinoma of the gastrointestinal tract (to include cancers of the colorectum, stomach, esophagus, appendix, and small bowel)
• The treating oncologist's recommendation must be for six or more cycles of standard-dose mFOLFOX chemotherapy (with or without concurrent bevacizumab, cetuximab, panitumumab, or trastuzumab). Intent of treatment may be either curative or palliative in nature.
• Completion of day 1 of cycle 1 of standard-of-care FOLFOX chemotherapy

You may not qualify if:

• Prior receipt of systemic chemotherapy in the 12 months prior to day 1 of cycle 1 of mFOLFOX (other than radiation-sensitizing chemotherapy)
• History of baseline neutropenia; defined as neutrophil count \<1500 in the 30 days preceding planned day 1 of cycle 1 of mFOLFOX
• History of baseline thrombocytopenia; defined as platelet count \<100,000) in the 30 days preceding planned day 1 of cycle 1 of mFOLFOX
• Patients with a history of an uncorrected bleeding condition that would preclude safe use of the dose adjustment algorithm, in the judgement of the enrolling investigator
• Patients who have started a new prescription anticoagulant (e.g. warfarin, heparin derivatives, or direct oral anticoagulants) in the 14 days preceding day 1 of cycle 1 of mFOLFOX
• Patients who are unable to provide informed consent
• Pregnant women

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (2)

• Kogan LG, Davis SL, Brooks GA. Treatment delays during FOLFOX chemotherapy in patients with colorectal cancer: a multicenter retrospective analysis. J Gastrointest Oncol. 2019 Oct;10(5):841-846. doi: 10.21037/jgo.2019.07.03.

  PMID: 31602321 BACKGROUND

• Wright HN, Tosteson TD, Hourdequin KC, Ripple GH, Fuld AD, Dragnev KH, Amin M, Muralikrishnan S, McGrath EB, Stannard MG, Schofield LL, Lord-Halvorson S, Tosteson ANA, Brooks GA. A pragmatic, single-arm clinical trial of a dose modification algorithm for preventing cytopenia-related delays during FOLFOX chemotherapy. Support Care Cancer. 2025 Aug 8;33(9):769. doi: 10.1007/s00520-025-09784-0.

  PMID: 40779182 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Appendiceal Neoplasms; Neutropenia; Thrombocytopenia

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Cecal Neoplasms; Cecal Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Blood Platelet Disorders

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Results Point of Contact

• Title: Gabriel Brooks
• Organization: Dartmouth Hitchcock Medical Center

gabriel.a.brooks@hitchcock.org

(603) 650-4344

Study Officials

• Gabriel A Brooks, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 26, 2020
• Study Start: October 15, 2020
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)